This randomized open label Phase III study aims to compare the safety, efficacy and duration of survival in patients with metastatic colorectal cancer who are treated with a 28 day oral regimen of 776C85 plus 5-FU or a five day regimen of intravenous 5-FU plus leukovorin. Response rates, duration of progression-free survival, quality of life, and medical resource use will also be compared between the two regimens.